Kornimate/medical-research-clean huggingface dataset:
a 24-52-week study to evaluate the long-term efficacy and safety of saredutant in patients with depression (magenta)

Conditions: Depressive Disorder

Summary: the purpose of the study is to evaluate the long-term efficacy and safety of saredutant in patients with depression. the primary objective is to evaluate the efficacy and safety of saredutant 100 mg once daily compared to placebo in the prevention of relapse of depressive symptoms in outpatients with major depressive disorder who achieved an initial response to 12 weeks of open-label treatment with saredutant.


Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder, as defined by diagnostic and statistical manual of mental disorders 4th edition (dsm-iv) criteria and confirmed by the semi-structured mini international neuropsychiatric interview (mini), recurrent episode. exclusion criteria: * total score of 28 or less on the montgomery and asberg depression rating scale (madrs). * clinical global impression (cgi) severity score of less than 4. * duration of the current depressive episode less than 2 months or greater than 2 years. * elderly patients with a mini-mental state examination (mmse) total score \<25. * patients with a history or presence of bipolar disorders or psychotic disorders. * patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence. * benzodiazepine or sedative-hypnotic use greater than 2 days per week during the month prior to entry into the acute phase. * patients who have used the following prior to entry into acute phase: antipsychotics within 3 months, fluoxetine within 1 month, monoamine oxidase inhibitors (maois) within 2 weeks, other antidepressant or mood-stabilizer (lithium, anticonvulsants) within 1 week. the investigator will evaluate whether there are other reasons why a patient may not participate.

Keywords: depression antidepressive agents controlled clinical trial
specified drug use-results survey of regnite

Conditions: Restless Legs Syndrome

Summary: this study is to investigate the long-term safety and efficacy and the information on the proper use of regnite® under conditions of daily clinical use.

sleeping condition and severity of restless legs syndrome (rls) were recorded at the start and during the treatment. the treatment period is scheduled to last 52 weeks in principle. for patients completing or discontinuing the use of regnite® within 52 weeks, follow up on the withdrawal and rebound syndrome will be conducted up to 4 weeks of completion or discontinuation.

Eligibility criteria:
inclusion criteria: * patients with moderate to severe idiopathic restless legs syndrome exclusion criteria: * patients with a history of hypersensitivity to any ingredients in regnite or gabapentin * patients with severely impaired renal function (creatinine clearance of less than 30 ml/min)

Keywords: gabapentin
a real-world study in china for the tecnis eyhance™ intraocular lens

Conditions: Cataracts

Summary: this is a prospective and retrospective, single-center, single-arm, open-label clinical study of the tecnis eyhance™ iol. the study will enroll up to 100 subjects from a single site in china. all subjects will be followed for 12 months postoperatively.


Eligibility criteria:
inclusion criteria: 1. male or female patients at least 22 years of age 2. have/had a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation or a history of implantation with tecnis eyhance intraocular lens 3. availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with study visits 4. voluntary participation indicated by the study informed consent form (icf) signed by the patient or legal guardian. exclusion criteria: 1. concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit 2. planned monovision correction (one eye designated for near correction). 3. any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study, affect visual acuity or may require surgical intervention during the course of the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).
voice analysis in patients with neurologic diseases

Conditions: Voice Disorders; Neurologic Disorder

Summary: in this observational pilot study, the investigators will record and assess voice samples from healthy participants and those participants affected by neurologic diseases to evaluate possible differences in voice features.

in this study, the investigators will evaluate the clinical features of healthy participants and those participants with neurologic disorders by applying dedicated clinical scales. also, the investigators will assess voice impairment by using perceptual examination tools. then, the investigators will apply spectral analysis to assess the main frequency components of voice in healthy participants and in patients affected by neurologic disorders with a prominent voice impairment. to distinguish between healthy participants and patients affected by various neurologic diseases, the investigators will apply a voice analysis based on support vector machine (svm) classifier that included a large number of features in addition to the main frequency components of voice. for these purposes, the investigators will assess in detail the sensitivity, specificity, positive predictive value, and negative predictive value and accuracy of all diagnostic tests. furthermore, the investigators will calculate the area under the receiver operating characteristic (roc) curves to verify the optimal diagnostic threshold as reflected by the associated criterion (ass. crit.) and youden index (yi). to assess possible clinical-instrumental correlations, the investigators will also use a modified algorithm of svm analysis to calculate a continuous numerical value (the likelihood ratio \[lr\]) providing a measure of voice impairment severity for each participant. voice recordings will be performed by asking participants to produce a specific speech task with their usual voice intensity, pitch, and quality. the speech task will consist of a sustained emission of a close mid-front unrounded vowel /e/ for at least 5 seconds. voice recordings will be collected by using a high-definition audio-recorder placed at a distance of 5 cm from the mouth. voice samples will be recorded in linear pcm format (.wav) at a sampling rate of 44.1 khz, with 24-bit sample size. voice analysis will consist of three separate processes: feature extraction, selection and classification. for feature extraction, the investigators will use the opensmile (audeering gmbh, germany), dedicated software. then, the investigators will select and classify voice feature by using svm algorithm included in weka.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of neurologic disorders exclusion criteria: * smoking * bilateral/unilateral hearing loss * respiratory disorders * conditions affecting the vocal cords, including nodules.

Keywords: voice analysis machine learning neurologic disorders
the impact of preoperative supplementation of zinc

Conditions: Surgery; Nutrition Disorders

Summary: 1. pre operative anthropometric assessment including : weight in kg, height/length and bmi 2. pre operative zinc supplementation (dose according to the age) for 7 days preoperatively for cases 3. postoperative data collection

postoperative data collection : * length of hospital stay * complication and sorting of them * lab withdrawal of inflammatory markers on 2-3 day postoperatively

Eligibility criteria:
inclusion criteria: 1. all children patients with hirschsprung disease admitted for surgical intervention with different ( age , sex ) 2. type of surgery : transanal pull through 3. whose parents or caregivers approve for the participation in the study exclusion criteria: 1. patients with emergency situations 2. whose parents or caregivers will not apply for the participation in the study
impact of early cardiac surgery in severe left endocarditis with neurological complications: a retrospective study

Conditions: Endocarditis; Neurologic Complication

Summary: surgical delay in severe endocardits, with neurological complications, is still debated. early surgery, if indicated, permits to avoid new embolic events, or to fix valvular damages, but can create or increase a cerebral hemorrage. hypothesis cardiac surgery, as soon as possible, if indicated, would reduce mortality, in severe left endocarditis, with neurological complications. primary objective to assess the impact of early versus late cardiac surgery on mortality at 1 year, in patients with severe endocarditis, with neurological complications. primary endpoint: 1) mortality at 1 year secondary endpoints: 1. analyze the factors associated with neurological degradation 2. evaluate the neurological tolerance of cardiac surgery.

surgical delay in severe endocardits, with neurological complications, is still debated. early surgery, if indicated, permits to avoid new embolic events, or to fix valvular damages, but can create or increase a cerebral hemorrage. hypothesis cardiac surgery, as soon as possible, if indicated, would reduce mortality, in severe left endocarditis, with neurological complications. primary objective to assess the impact of early versus late cardiac surgery on mortality at 1 year, in patients with severe endocarditis, with neurological complications. primary endpoint: 1) mortality at 1 year secondary endpoints: 1. analyze the factors associated with neurological degradation 2. evaluate the neurological tolerance of cardiac surgery. methods multicentric study (7 french university hospitals). retrospective study: from august 2010 to december 2017. propensity score matching study. 192 patients are included.

Eligibility criteria:
inclusion criteria: * left endocarditis * with indication of cardiac surgery * severe endocaditis (sofa score \> or = 3/16) * with pre operative neurological complications exclusion criteria: * age \< 18 * right endocarditis without left endocarditis * no severe endocarditis (sofa score \< 3) * ne pre operative neurological complications * endocarditis without indication of cardiac surgery
efficacy in alveolar bone regeneration with autologous mscs and biomaterial in comparison to autologous bone grafting

Conditions: Alveolar Bone Atrophy

Summary: a randomized controlled clinical multi center trial to assess the efficacy of a combination of autologous mesenchymal stem cells and biomaterial in jaw bone regeneration prior to dental implant placement in comparison to standard autologous bone block grafting.

a phase iii multi center clinical trial, randomized and controlled.the study subject is lacking one or more sheet behind the canine in the upper or lower jaw, and the alveolar ridge is too narrow to place a dental implant. the test objects will have augmentation using autologous mesenchymal stromal cells and a biomaterial, biphasic calcium phosphate. the control is the traditional bone block from the ramus.

Eligibility criteria:
inclusion criteria: * healthy, non smoking patients in need of dental implants in the upper or lower jaw, with loss in vertical height and less that 4 mm in lateral width. exclusion criteria: * general contraindications for dental and/or surgical treatments * contraindications for both bone marrow harvesting and bone grafts * history of any malignant diseases * concurrent or previous radiotherapy of head and neck region * history of contagious diseases (hiv, htlv and/or syphilis seropositivity, hepatitis b or c infection) * uncontrolled diabetes mellitis, e.g. patients with diabetes not regulated with medications or diet. this will be verified based on patient's history and concurrent hba1c levels (hba1c \> 53 mmol/mol). * inflammatory and autoimmune disease of the oral cavity. * concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy.

Keywords: maxilla mandible, msc rct bone regeneration multicenter
cardiovascular metabolic remodeling in shock

Conditions: Shock

Summary: the aim of the study is to increase our knowledge of energy dysfunction in the cardiovascular dysfunction observed during shock states by analysing the omics molecules involved.

to do this, the investigators chose to carry out an in-depth study of the different metabolic pathways, using metabolomic analysis of plasma, targeting the cardiovascular metabolism of patients admitted to intensive care for septic and non-septic shocks.

Eligibility criteria:
inclusion criteria: * patient aged between 18 and 75. * patient admitted to intensive care for shock treated with a vasoactive or inotropic amine (adrenaline, dobutamine or noradrenaline).patient undergoing invasive mechanical ventilation for less than 24 hours (or admitted to intensive care for less than 24 hours if the patient arrived intubated) and for a foreseeable duration of ventilation of at least 48 hours. * patient, or relative if the patient is not competent, who has read and understood the information letter and does not object to participation in the research, or emergency procedure in the absence of a relative. * urine or blood pregnancy test if a sample is taken as part of routine negative care (if woman of childbearing age). exclusion criteria: * moribund patient (death expected within \< 24 hours) and/or decision to limit or stop treatment on admission to intensive care. * pregnant, parturient or breast-feeding woman. * patient not suitable for enteral calorie intake. patient with a history of: advanced chronic renal failure ; advanced chronic liver failure. * incapacitated patient of full age (under guardianship, curatorship) or deprived of liberty by court order. * patient already taking part in an interventional study.

Keywords: metabolic remodelling shock states cardiovascular dysfunction metabolomics
a phase 2 trial of ami multistem® therapy in subjects with non-st elevation acute myocardial infarction

Conditions: Heart Attack; NSTEMI

Summary: this is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility of ami multistem therapy in subjects who have had a heart attack (non-st elevation mi).


Eligibility criteria:
inclusion criteria: * subjects of either gender, 18-85 years of age, inclusive * diagnosis of non-st elevation myocardial infarction (nstemi) * left ventricular ejection fraction (lvef) between ≥ 25 and ≤ 45% exclusion criteria: * previous coronary artery bypass graft (cabg) * previous autologous, allogeneic bone marrow or peripheral stem cell transplant * previous solid organ transplant * anticipated need for additional planned coronary revascularization procedure(s) * hemodynamic instability * mechanical complications of the index acute myocardial infarction

Keywords: stem cells
a study to investigate the efficacy and safety of ms-553 in cll/sll

Conditions: Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: this is a phase i/ii, single arm, multi-center, open-label clinical trial of ms-553 in patients with cll/sll whose disease relapsed after or was refractory to at lease 1 prior therapy (chemotherapy and/or targeted drug therapy, which must include btk inhibitor therapy) and who are indicated for treatment per iwcll2018.


Eligibility criteria:
inclusion criteria: * age 18 years or older, male or female. * diagnosis of cll/sll per iwcll2018 criteria. * patients with relapsed or refractory cll/sll who have failed at least 1 prior therapy (chemotherapy and/or targeted drug therapy, which must include btk inhibitor therapy), are indicated for treatment per iwcll2018. * measurable lesions detected by contrast-enhanced computed tomography (ct): at least one lymph node with a maximum axis of more than 1.5 cm and one measurable vertical dimension. * who/ecog performance status of 0 to 2. * patients with an estimated survival of more than 3 months. exclusion criteria: * biopsy-proven and pathologically confirmed current or past transformation to richter's syndrome. * patients with active and uncontrolled autoimmune cytopenia, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura. * patients who have received any of the following treatments within 14 days prior to the first dose: * major surgery; * glucocorticoids (at a dose equal to or greater than 20 mg/day prednisone or equivalent), unless used by inhalation, topical or intraarticular route, or unless necessary for premedication before and after iodinated contrast dye. after discussion with the sponsor, steroid therapy at high doses for an extended period may be allowed under the following circumstances: 1. treatment of autoimmune hemolysis or autoimmune thrombocytopenia associated with cll/sll; 2. short-term (within 14 days) use to treat inactive infections of diseases unrelated to cll/sll (e.g. arthritis, asthma), which results in acute exacerbation, including steroid dose modifications required for adrenal insufficiency; * cytotoxic chemotherapy or biologic therapy, excepting bcr pathway kinase inhibitors for which a washout of 24 hours prior to the first dose is required. * toxicity from prior anti-tumor therapy (chemotherapy, radiotherapy, or biotherapy) did not restore to ≤ grade 1 (except for alopecia); atrial fibrillation from prior treatment with btk inhibitors did not restore to ≤ grade 2. * central nervous system (cns) leukemia or lymphoma, including a history of asymptomatic, previously treated cns disease.
a multiple dose study of pd-0360324 in patients with active cutaneous lupus erythematosus

Conditions: Cutaneous Lupus Erythematosus

Summary: this study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of pd-0360324 in patients with cutaneous lupus erythematosus. changes in disease activity will also be evaluated.

the trial was terminated prematurely on oct 15, 2013 due to a business decision. the decision to terminate the trial was not based on any clinical safety or efficacy concerns.

Eligibility criteria:
inclusion criteria: * male and/or female subjects between the ages of 21 to 70 who have a clinical diagnosis of either discoid cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus with or without systemic lupus erythematosus prior to screening that has been confirmed by evaluation of skin biopsy sample. * active disease at both screening and baseline (day 1) defined by a clasi score of greater than or equal to 10. * intolerance to antimalarial therapy or more than 3 months of antimalarial therapy with disease activity. exclusion criteria: * use of greater than or equal to 20 mg or prednisone (or equivalent) within 3 months of day 1. * signs or symptoms or relevant history of a viral, bacterial, fungal, and parasitic infection, or recent history of repeated infections * subjects with evidence of past or active tuberculosis * pregnant, planning to get pregnant, and/or lactating females or males planning to father a child within time period of the study or subsequent exclusionary period.

Keywords: safety and tolerability cutaneous lupus erythematosus efficacy
a phase 2 study of mutant-selective pi3kα inhibitor, rly-2608, in adults and children with pik3ca related overgrowth spectrum and malformations driven by pik3ca mutation

Conditions: PIK3CA-Related Overgrowth Spectrum (PROS); Lymphatic Malformations; Vascular Malformations; PIK3CA Mutation; CLOVES Syndrome; Klippel Trenaunay Syndrome; Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)

Summary: this is a 3-part phase 2 randomized study evaluating the safety and efficacy of the mutant-selective pi3kα inhibitor, rly-2608, in adults and children with pik3ca related overgrowth spectrum (pros) and malformations driven by pik3ca mutation. part 1 is a dose selection, part 2 is a basket design with exploratory single-arm cohorts for various subpopulations of participants, and part 3 is randomized, double-blinded study vs placebo.


Eligibility criteria:
key inclusion criteria: * the participant must have a clinical diagnosis of pros or a malformation within the issva 2018 classification. * one or more documented activating pik3ca mutation(s) that are targeted by selective pi3kα inhibitors in lesional tissue and/or cell-free dna from the lesion or blood * lansky (\<16 yo) or karnofsky (≥16 yo) performance status of ≥50. * agree to provide archived lesional fluid and/or tissue or be willing to undergo pretreatment lesional biopsy (if considered safe and medically feasible) to assess pik3ca status. key exclusion criteria: * history of hypersensitivity to pi3k inhibitors. * any factors that increase the risk of qtc prolongation or risk of arrhythmic events * clinically significant, uncontrolled cardiovascular disease * received disease-directed therapy prior to the first dose of study drug: 1. systemic therapy within 5 half-lives of the drug or 14 days, whichever is longer and received antibody therapy within 28 days. 2. local therapy including radiation, surgery, or other procedures within 28 days; lesion(s) must have demonstrated progression after the procedure.
methylprednisolone in covid-19 patients (methyl19lgh)

Conditions: SARS-CoV Infection; SARS (Severe Acute Respiratory Syndrome)

Summary: in covid-19 deep airway and alveolar destruction occurred due to inflammatory reaction resulting into severe pneumonia. in covid-19, lung injury is not only due to viral damage to tissue, but it is also due to immune response that leads to activation of inflammatory cells and release of cytokines. in covid-19 acute respiratory distress syndrome ards is produced due to mucinous or cellular fibromyxoid exudates, desquamation of pneumocytes and alveolar damage and hyaline membrane development and within 5-7 days disease become more aggressive due to pneumonia and respiratory failure. it is important to start the prompt and strengthen treatment for suppression of inflammatory response and cytokine storm. methylprednisolone are the traditional immunosuppressive drugs. they are important and effective to delay the pneumonia progression and treating the ards. corticosteroids are broadly used as treatment for ards and there was an evidence for its efficacy for treating sars and decreasing mortality of sars in the past. however for covid-19 corticosteroids efficacy and safety usage is still under clinical trials

all new decision and new interventions that are made for decreasing dependency of ventilator in patients and decreasing patients mortality would have played a great role on global public health. the aim of the study is to address the efficacy of methlyprednisolone for the treatment of covid-19 patients and its clinical outcome at a tertriary care hospital.

Eligibility criteria:
inclusion criteria: * all patients of all ages, males, and females who will be diagnosed covid-19 positive by rt-pcr with moderate illness. * patients having classical radiological lesions of covid-19 on x-ray chest or hrct chest. * respiratory rate \> 22/ min and \>50% of radiological involvement of lung with typical lesions. * fio2 remain static or improving, along with \> 30% deranged ≥ 2 biochemical markers crp \> 20 mg/l, ldh \> 600 u/l, d.dimer \> 0.5mg/l or 500 ng/ml, serum ferritin \< 500 ng/ml or mcg/l will be included in clinical trial. exclusion criteria: * heart failure, * cardiac arrest * decompensated liver cirrhosis, * decompensated psychiatric disorder * contraindication for corticosteroids * leukopenia \<1000/mm or neutropenia \<500/mm * recent or history of bone marrow or solid organ transplantation

Keywords: covid-19 methylprednisolone clinical outcome